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  • Location

    Delft, Netherlands

  • Job title:

    QA Operations Manager

  • Sector:

  • Job ref:

    44560

  • Startdate:

    2020-08-06

The Company

Our partner is a multinational company active in everyday Consumer Healthcare and has a product portfolio of more than 100 brands sold in more than 60 countries.

 

Role Description

  • To collaborate with the Quality Systems Manager to  ensure that the global QMS in the company is, implemented and maintained throughout the organization in compliance with ISO13485 and MDR.
  • To oversee the CMO´s quality compliance and strategically develop the processes and collaborations to increase efficiency and quality assurance.

 

  • ISO13485 compliance of QMS for MD
  • ISO13485 compliance of Quality operations including CMOs for MD
  • Development of current global system for cosmetic quality assurance
  • Development of compliance of Quality operations including CMOs for cosmetics

 

  • Support the Management Representative (MR) with the promotion and ensuring awareness of regulatory and customer requirements throughout the organization.
  • Issuing new quality documents (SOPs, Work Instructions, Templates and Forms) in compliance with ISO13485
  • Review quality documents and approve before implementation
  • Act as Project Manager in assigned Change control projects for MD and cosmetics
  • Participate in Risk Management team.
  • Collaborate in establish and maintain a system of audits.
  • Prepare and conduct internal and external audits, establish audit reports and control follow up in collaboration with Lead auditor (external)..
  • Review and approve subcontracted activities which may impact on ISO processes, in close collaboration with Supply Chain Management team.
  • Review and approval PMS Strategy & Plan and PMS reports.
  • Release products; and authorized to stop processes and product release
  • Review QMS and report to Top Management during the Management Review Meeting on the performance, suitability, adequacy and effectiveness of QMS and adherence to (inter)national legislation and requirement and any need for improvement.
  • Set up validation teams and assigning roles related to production.
  • Determine quality related training and development needs and provide quality trainings

 

 

Responsibilities

  • approving any subcontracted activities which may impact on ISO processes
  • control Risk Management Process
  • approving QA documents from the Quality Management System, Risk management processes, Change control processes, deviation reports, validations concerning ISO processes;
  • act as Compliance Manager in compliance with established SOPs which may impact on ISO processes, see RASCI Matrix mentioned below.

 

  • Taking decisions about stopping processes and releases or releases by concession Non-Pharmaceuticals.
  • Contact Person for Notified Bodies and Authorities about assigned Change Control Plans.
  • Approving/disapproving QA documents from the Quality Management System, Risk management processes, Change control processes, Corrective and Preventive Actions, validations concerning ISO processes.
  • Implement changes according to ISO and medical devices/cosmetics legislation and guidelines.

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